崗位職責(zé):
1.根據(jù)工藝開發(fā)進度,組織實施中間樣品、non-GMP相關(guān)方法開發(fā)和檢驗工作,如結(jié)合活性、生物活性HCP、HCD、protein A殘留等。
According to the progress of process development, organize and implement the relevant method development and inspection assay for in process and non-GMP samples, such as Binding assay、Bioactivity、HCP、HCD、protein A residue,etc.
2.負責(zé)起草檢測方法和儀器操作的SOPs,包括分析方法、儀器操作,并進行方法轉(zhuǎn)移至QC部門。
Responsible for drafting SOPs related to method and instrument operation and transfer the methods to the QC department.
3.負責(zé)生化相關(guān)分析方法開發(fā)報告的起草和審核工作,以及質(zhì)量板塊CTD注冊資料的撰寫。
Responsible for drafting and reviewing method development reports related to biochemical assay and the write the CTD registration materials for the quality section.
4.負責(zé)管理、維護保養(yǎng)檢驗設(shè)備,確保檢驗設(shè)備可正常運行且在有效期內(nèi)。
Be responsible for the management, maintenance and inspection of testing equipment to ensure that the testing equipment can operate normally and is within the validity period.
5.負責(zé)AD生化團隊的日常管理、年度培訓(xùn)、績效評價、成本優(yōu)化等。
Responsible for daily management, annual training, performance evaluation, cost optimization, etc. of the AD biochemical team.
6.完成AD經(jīng)理分配的其他工作和職責(zé)。
Any other job and responsibilities assigned by AD manager.
任職要求:
1、至少具有藥學(xué)或生物相關(guān)專業(yè)碩士學(xué)歷(或中級專業(yè)技術(shù)職稱或執(zhí)業(yè)藥師資格)。
Must, at a minimum, have an educational qualification of an master course in pharmacy or biological related sciences (or with a technical title at middle grade or licensed pharmacist)
2、至少3年從事抗體類生物制品生化相關(guān)分析的實踐經(jīng)驗。
At least 3 years hand on experience in biochemical analysis of antibody biologics.
3、能夠閱讀相關(guān)的英文資料。
Be able to read related English materials.